510(k) BK030032

Device

Blood Specimen Collection Devices - Vacuum

Applicant

Greiner Bio-One GmbH

510(k) number

BK030032

Product code

JKA  

Decision

Substantially Equivalent (SE)

Decision date

2003-07-18

Date received

2003-05-21

Regulation

862.1675

Classification name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Medical specialty

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Review panel

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Clearance type

510(k) Traditio

Third party reviewed

No